Scratch Behavior Under Standard of Care

NCT03898427 | Completed

• 1 other identifier: H-38472
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Wrist-worn accelerometers and associated data analysis platforms will provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic Atopic Dermatitis (AD) population. The overall research aim is to evaluate the sensitivity of digital devices to capture drug-induced (standard of care treatments; SOC) quantitative changes in nighttime scratch and sleep quantity in AD subjects. In the current study, the investigators aim to evaluate the ability of wrist-worn accelerometers to detect significant and clinically meaningful changes in scratch behavior and sleep quantity in patients with symptomatic AD aged 2 to 75 years, receiving topical SOC treatment for AD. To evaluate this experimental paradigm, using wearable accelerometers, traditional patient-reported outcome measures/observer-reported outcome (ObsRO) (PRO/ObsRO), thermal videography and physician assessments of AD will be assessed in a well-controlled observational methodology study that has both an in-patient and out-patient portions within the study.

Conditions

Atopic Dermatitis

Keywords

Wearable devices; Scratch; Sleep

Outcome Measures

Primary Outcomes (2)

• Quantification of scratch using GENEActiv watches to assess triaxial accelerometry following standard of care (SOC) treatments

  One GENEActiv watch will be used on each hand at a sampling rate of 100 Hz to measure movement in the x, y, and z direction. The movement will be analyzed using the algorithm described by Cole et al. to differentiate between periods of wakefulness and sleep following SOC treatments.

  From enrollment through the end of visit 5 (15 days +/- 3 days).

• Quantification of sleep using polysomnography following SOC treatment

  Polysomnography (PSG) will be used to report the number of sleep occurrences and appropriate sleep staging following SOC treatments based on the scoring guide provided by the American Academy of Sleep Medicine (AASM). The following sleep stages will be scored: Stage W (wakefulness), Stage N1 (NREM 1), Stage N2 (NREM 2), Stage N3 (NREM 3), Stage N (NREM), and Stage R (REM).

  From enrollment through the end of visit 5 (15 days +/- 3 days).

Study Arms (1)

Individuals with atopic dermatitis

Sensor technology and digital measures will be used to evaluate scratch and sleep in individuals with atopic dermatitis receiving standard of care treatments (SOC) who will wear watch-like wrist actigraphy devices, sleep monitor, polysomnography, and videography.

Device: Wrist Actigraphy Devices; Device: Polysomnography; Device: Videography

Interventions

Wrist Actigraphy Devices DEVICE

A watch-like wearable sensor

Also known as: GENEActiv Watch

Individuals with atopic dermatitis

Polysomnography DEVICE

Sleep Monitor

Individuals with atopic dermatitis

Videography DEVICE

Thermal Camera

Individuals with atopic dermatitis

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with atopic dermatitis

You may qualify if:

• Male or female subjects aged between ≥2 years of age and \<75 years of age at Day 1.
• Written informed consent from subject/parent(s)/guardian(s) and assent from the subject, where assent is applicable (for those subjects under 18 years of age).
• Subject and parent(s)/guardian(s) are willing and able to comply with study instructions, study visits, and procedures.
• Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s) in the case of minors).
• Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka.

You may not qualify if:

• Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant finding at screening that precludes subject's participation in study activities.
• Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.
• Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
• Has unstable AD (Total BSA\>40%) (including a significant active systemic or localized infection).

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Evans Biomedical Research Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kevin C Thomas, PhD, MBA

  Boston University, Department of Anatomy and Neurobiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: April 4, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)